Recall Z-1912-2024— Stryker Orthopaedics
Class II · Ongoing
Class II FDA medical device recall by Stryker Orthopaedics, initiated 2024-04-15. It names 3 FDA 510(k) clearances: K220459, K193515, K172301. Product: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04. Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment.
- Recalling firm
- Stryker Orthopaedics
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-15
- Firm location
- Montclair, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K220459 — Mako Total Knee Application
- K193515 — Mako Total Knee Application
- K172301 — Mako Partial Knee Application
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
Reason for recall
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Data sourced from openFDA. This site is unofficial and independent of the FDA.